Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
Not Applicable
Completed
- Conditions
- Menorrhagia
- Interventions
- Registration Number
- NCT01266759
- Lead Sponsor
- Mansoura University
- Brief Summary
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 95
Inclusion Criteria
- Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
Exclusion Criteria
- Menorrhagia of endocrine or systemic origin
- other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Norethisterone Acetate Norethisterone Acetate tablets - 5mg Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment NuvaRing NuvaRing For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.
- Primary Outcome Measures
Name Time Method Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
- Secondary Outcome Measures
Name Time Method Haemoglobin and serum ferritin at the end of study (cycle 3)
Trial Locations
- Locations (1)
Mansoura University Hospitals,OB/GYN department
🇪🇬Mansoura, Dakahlia Governorate, Egypt